COVID-19 vaccine guidance for patients with cancer participating in oncology clinical trials.
COVID-19 vaccine guidance for patients with cancer participating in oncology clinical trials.
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DOI：
10.1038/s41571-021-00487-z
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发表时间：
2021-05
期刊：
影响因子：
--
通讯作者：
COVID19 and Cancer Clinical Trials Working Group
中科院分区：
文献类型：
--
作者：
Desai A;Gainor JF;Hegde A;Schram AM;Curigliano G;Pal S;Liu SV;Halmos B;Groisberg R;Grande E;Dragovich T;Matrana M;Agarwal N;Chawla S;Kato S;Morgan G;Kasi PM;Solomon B;Loong HH;Park H;Choueiri TK;Subbiah IM;Pemmaraju N;Subbiah V;COVID19 and Cancer Clinical Trials Working Group
新出现的有效性数据已导致全球多个国家批准或紧急使用COVID-19疫苗。大多数COVID-19疫苗的试验排除了患有活动性恶性肿瘤的患者，因此目前有关疫苗在癌症患者中的安全性、耐受性和有效性的数据有限。鉴于COVID-19大流行带来的风险，需要迅速解决有关在参与研究性抗癌疗法试验的患者中使用COVID-19疫苗的决定。患者不应该在参加肿瘤临床试验和接受COVID-19疫苗之间做出选择。临床试验申办者、研究者和治疗医生需要为目前已入组或可能寻求入组临床试验的癌症患者提供COVID-19疫苗接种的操作指导。考虑到COVID-19在癌症患者中的高发病率和死亡率，疫苗接种的益处可能远远超过疫苗相关不良事件的风险。在此，我们为参与肿瘤临床试验的患者提供可操作的COVID-19疫苗指导。在我们看来，持续的高质量肿瘤治疗要求癌症患者，包括参与试验的患者，优先接种COVID-19疫苗，这不应影响试验资格。癌症患者因COVID-19而发病和死亡的风险很高。COVID-19疫苗的快速发展为减轻疾病带来了新的希望。在此，COVID-19和癌症临床试验工作组呼吁优先考虑癌症患者，重要的是包括参与肿瘤临床试验的患者，进行COVID-19疫苗接种。作者还为参与肿瘤临床试验的患者提供了可操作的COVID-19疫苗指导。
Emerging efficacy data have led to the emergency use authorization or approval of COVID-19 vaccines in several countries worldwide. Most trials of COVID-19 vaccines excluded patients with active malignancies, and thus data on the safety, tolerability and efficacy of the vaccines in patients with cancer are currently limited. Given the risk posed by the COVID-19 pandemic, decisions regarding the use of vaccines against COVID-19 in patients participating in trials of investigational anticancer therapies need to be addressed promptly. Patients should not have to choose between enrolling on oncology clinical trials and receiving a COVID-19 vaccine. Clinical trial sponsors, investigators and treating physicians need operational guidance on COVID-19 vaccination for patients with cancer who are currently enrolled or might seek to enrol in clinical trials. Considering the high morbidity and mortality from COVID-19 in patients with cancer, the benefits of vaccination are likely to far outweigh the risks of vaccine-related adverse events. Herein, we provide operational COVID-19 vaccine guidance for patients participating in oncology clinical trials. In our perspective, continued quality oncological care requires that patients with cancer, including those involved in trials, be prioritized for COVID-19 vaccination, which should not affect trial eligibility. Patients with cancer have a high risk of morbidity and mortality from COVID-19. The rapid development of COVID-19 vaccines has provided new hope of mitigating the disease. Herein, the COVID19 and Cancer Clinical Trials Working Group calls for prioritization of patients with cancer, importantly including those participating in oncology clinical trials, for COVID-19 vaccination. The authors also provide operational COVID-19 vaccine guidance for patients participating in oncology clinical trials.
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